Quality Assurance Manager

Quality Assurance Manager

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. 

This 206,878 square-foot facility, located in the Philadelphia area is Catalent’s global Center of Excellence for Clinical Supply Packaging.  Catalent offers GMP secondary packaging and clinical labeling services throughout our global network. Packaging can be configured to hold a single product, or multiple products as determined by study requirements. We offer manual patient kit assembly along with semi-automated and automated wallet sealing and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and those with minimal to zero allowable time out of environment, we can perform secondary packaging in refrigerated and frozen packaging rooms or over dry ice depending upon your project needs.  Using our Clinicopia global labeling system with its multi-lingual label phrase library we can design single panel, booklet labels or our unique Peel-ID™ safe storage labels for your studies. Single panel and Peel-ID™ safe storage labels can be conveniently reviewed and approved online via our Fusion portal before being printed and inspected at our facilities.

Catalent Pharma Solutions in Philadelphia, PA is hiring a Quality Assurance Manager. The Manager is responsible for coordinating and implementing activities to attain strategic objectives within a single functional area or department and looks to his or her direct supervisor or other peers within the industry for guidance.  

This is a full-time, salaried role, on-site.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Write, revise, and/or review SOPs for approval
• Assist in preparing the site for inspection by regulatory authorities and participating in regulatory inspections, as required
• Assign project deliverables to team members with appropriate due dates for project completion
• Provide team members with leadership, guidance, mentoring, coaching and feedback against performance and development objectives
• Review and approve quality records in TrackWise
• Conduct performance reviews, recommend salary increases, and career planning for all direct reports
• Represent quality department on project teams, management teams and other internal forums
• All other duties as assigned

The Candidate:

• Bachelor of Science Degree is required
• At least ten years of experience working in Quality areas in the Pharmaceutical/medical device industry with management responsibilities is preferred
• Experienced working in a cGMP management role with an understanding of compliance and associated regulations is preferred
• Good computer skills, including in-depth knowledge of MS Office, Electronic Document Management Systems (EDMS), TrackWise and ComplianceWire preferred
• In-depth knowledge of Quality Assurance and Regulatory Affairs as applicable to the Pharmaceutical industry
• Required Leadership skills include excellent interpersonal and communication skills with cross-functional teams, the strong ability to lead, mentor, train, motivate, direct and empower a team, influence and lead change, and contribute strategic, analytical insight for problem solving and work with the team to identify gaps and develop continuous improvement suggestions/ideas
• Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds

Why You Should Join Catalent:

• Defined career path and annual performance review and feedback proces